Phase 2 Study Comparing Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy and Immune Checkpoint Inhibitor Versus Docetaxel in Advanced or Metastatic Non-Small Cell Lung Cancer After First Progression on Front-line Immune Therapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Olvimulogene nanivacirepvec Olvi-Vec, an intravenously delivered oncolytic vaccinia virus, in combination with platinum-based chemotherapy and a physicians choice of immune checkpoint inhibitor ICI compared to docetaxel in patients with advanced or metastatic non-small-cell lung cancer NSCLC. This Phase 2, open-label, randomized study focuses on patients who have shown first disease progression while on front-line or maintenance ICI therapy following platinum-doublet chemotherapy. The study aims to test if Olvi-Vec can activate the immune system and make tumors more responsive to chemotherapy in NSCLC patients without certain targetable genetic alterations. Participants will be assigned to one of several groups. Initial cohorts receive varying doses of Olvi-Vec over 3 or 4 consecutive days, followed 2 to 3 weeks later by platinum-doublet chemotherapy combined with a physician-chosen ICI. The experimental arm will use the Olvi-Vec dose and schedule selected from these cohorts, followed by platinum-based chemotherapy plus ICI. The comparator arm receives docetaxel starting in week 0 and continuing until disease progression is confirmed. Patients in the comparator arm with disease progression may cross over to receive the experimental treatment if eligible. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression-free survival up to 12 months after randomization. Researchers will monitor treatment safety and side effects for up to 36 months. Additional measures include overall survival, disease control rate, and treatment response duration. Scheduled visits will involve laboratory tests, imaging, and clinical evaluations to track health and disease status throughout the trial.

Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer